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Maturation of the Autonomic Nervous System in Prematures

This study is currently recruiting participants.
Verified January 2013 by Rambam Health Care Campus
Sponsor:
Information provided by (Responsible Party):
wamir, Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01423942
First received: August 23, 2011
Last updated: January 14, 2013
Last verified: January 2013
History of Changes
  Purpose

The purpose of this study is to try to evaluate the maturation of the autonomic nervous system in prematures.


Condition
Analysis, Event History

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Maturation of the Autonomic Nervous System in Prematures

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Herat rate variability (HRV) characteristics [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    It is well known that maturation of the autonomic nervous system can be detected by heart rate variability in children. The purpose of this study is to apply HRV characteristics in premature infants and try to evaluate if there are noticable changes in these parameters both in "healthy" and diseased premature infants longitudinally during their stay at the NICU. Outcome measures to be studied are very low frequency ( VLF), low-frequency ( LF), high frequency (HF) frequency bands in the power spectrum density (PSD) of HRV records.


Estimated Enrollment: 300
Study Start Date: October 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Detailed Description:

To evaluate the maturation of the autonomic nervous system in prematures by using heart rate variability analyses.

  Eligibility

Ages Eligible for Study:   up to 100 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Prematures

Criteria

Inclusion Criteria:

  • All prematures
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01423942

Contacts
Contact: Amir Weissman, MD 972-4-8541779
Contact: Shraga Blazer, MD 972-4-8542219

Locations
Israel
RMC Recruiting
Haifa, Israel
Contact: Amir Weissman, MD     0502061366 ext 972     wamir@ambam.health.gov.il    
Principal Investigator: Amir Weissman, MD            
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Amir Weissman, MD RMC
  More Information

No publications provided

Responsible Party: wamir, MD, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01423942     History of Changes
Other Study ID Numbers: RMB-0215-11
Study First Received: August 23, 2011
Last Updated: January 14, 2013
Health Authority: Israel: Ministry of Health

ClinicalTrials.gov processed this record on June 17, 2013